Understanding and implementing efficient analytical methods development and validation
by AAI Pharma Inc.
This white paper by AAI Pharma describes the development and validation process for investigational new drug (IND), new drug application (NDA) and abbreviated new drug application (ANDA) submissions, and advances in technology and equipment with respect to analytical methods development and the validation process. Success in these areas can be attributed to several important factors, which in turn will contribute to regulatory compliance, including the collective experience level of the scientists behind development and validation, along with a strong mentoring and training program.
| Published: | 2003 |
| Format: | |
| Length: | 6 pages |
| Type: | White paper |
| Language: | English |
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